IMx CA 125 Mode 1 Calibrator, list 7A89-40; Abbott Laboratories, Abbott Park, IL 60064
FDA device recall Z-0319-04 · posted 2004-01-10 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4
- Action taken
- Field Correction recall by letter dated 11/25/03 to all customers receiving the affected reagents. The accounts were informed of the incorrect control package insert referenced in the product information letter shipped with each CA 125 product. The letters contained the correct control package insert number, 34-1047/R4, and stated that all CA 125 assay product inserts will be updated shortly to include the revised storage instructions for the CA 125 Calibrators and Controls.
- Root cause
- Other
- Status
- Terminated
- Product code
- LTK
- Distribution
- Nationwide and internationally through Abbott subsidiaries in Argentina, Aruba, Australia, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Ecuador, Germany, Peru, Hong Kong, India, Jamaica,
- Date initiated
- 2003-11-25
- Date posted
- 2004-01-10
- Date terminated
- 2004-07-26
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMX CA 125 (K964185) | Abbott Diagnostics | 1997-11-04 |